Evaluation of Safe Use of SECURIDRAP® SELFIA®

Launched by GROUPE MULLIEZ-FLORY · Aug 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a special type of bedding called SECURIDRAP® SELFIA®, which is designed for patients who may experience confusion, cognitive difficulties, or behavioral issues. The trial is taking place in nine medical facilities in France and aims to ensure that this updated version of the bedding is safe for use. Researchers will closely monitor participants for any unwanted side effects while using the bedding.

To be eligible for the trial, participants must be at least 18 years old and have a doctor’s prescription for the SECURIDRAP® SELFIA®. They should also have some level of disorientation or cognitive impairment, be at risk of falling from bed, and be under guardianship if needed. Participants will need to provide their agreement to take part in the study. Throughout the trial, participants can expect to be closely observed for their safety and comfort while using the bedding. It's important to note that certain individuals, like those with severe agitation or who are currently involved in other clinical studies, cannot participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient at least 18 years old
• • Patient having a medical prescription for SÉCURIDRAP® SELFIA®
• • Patient in phase or state of disorientation
• • Patient with nocturnal behavior disordre
• • Patient with major cognitive impairment
• • Patient at risk of falling into bed
• • Patient subject to guardianship or curatorship
• • Patient beneficiary or affiliated to a social security scheme
• • Patient who has given their participation agreement aand informed consent
• Exclusion Criteria:
• • Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
• • Patient in psychiatry
• • Patient with severe agitation
• • Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
• • Patient with intolerance to the medical device
• • Patient able to extract himself from SÉCURIDRAP® SELFIA®
• • Patient able to unlock the bed rails by himself
• • Patient without social coverage or not benefiting from it through a third party
• • Patient minor, pregnant woman, persons deprived of their liberty
• • Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion